Safety Study of Dabigatran in CADASIL (NCT01361763) | Clinical Trial Compass
UnknownPhase 2
Safety Study of Dabigatran in CADASIL
Italy50 participantsStarted 2011-06
Plain-language summary
This study is a Phase II, randomized, crossover trial designed to compare one fixed dose of dabigatran with open-label use of ASA in patients affected by CADASIL; the study is a safety trial, and the primary objective is to assess that dabigatran is not less safe than ASA in subjects with CADASIL.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients aged 18 years or older diagnosed with CADASIL according genetic test will be eligible.
Exclusion Criteria:
* Treatment with antiplatelet drugs for a condition different from CADASIL;
* conditions associated with an increased risk of bleeding (major surgery within the previous month, planned surgery or intervention within the next 3 months;
* history of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding;
* gastrointestinal hemorrhage within the past year;
* symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days; hemorrhagic disorder or bleeding diathesis;
* need for anticoagulant treatment of disorders other than atrial fibrillation; fibrinolytic agents within 48 hours of study entry; uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg and/or diastolic blood pressure greater than 100 mm Hg);
* recent malignancy or radiation therapy (within 6 months) and not expected to survive 3 years; severe renal impairment (estimated creatinine clearance 30 mL/min or less);
* active infective endocarditis;
* active liver disease (including but not limited to persistent ALT, AST, Alk Phos greater than twice the upper limit of the normal range; active hepatitis C (positive HCV RNA);
* active hepatitis B (HBs antigen +, anti HBc IgM +), active hepatitis A);
* women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of con…